Original Title: Baricitinibe (Olumiant) para pacientes com artrite reumatoide ativa, moderada a grave

Authors' objectives: Does the use of baricitinib (Olumiant®) in adult patients with established moderate to severe RA, who have responded inadequately to, or who are intolerant to one or more non-biological and biological DMARDs, provide clinical benefit (efficacy and safety) comparable to biological DMARDs and tofacitinib?

Authors' results and conclusions: The CONITEC’s members, on February 5th, 2020, decided to recommend the incorporation of baricitinib (Olumiant®) in the scope of SUS, for the treatment of patients with established moderate to severe rheumatoid arthritis, who have responded inadequately to, or who are intolerant to one or more non-biological and biological disease-modifying antirheumatic drugs, subject to reassessment of the set of available drugs in the same treatment stages, based on economic evaluation. The Deliberation Record No. 501/2020 was signed.

Authors' recommendations: Scientific evidence: Baricitinib was compared with adalimumab in a randomized controlled trial (RCT), and tofacitinib in a network meta-analysis. Compared with adalimumab, baricitinib demonstrated similarity in outcomes of ACR50 and fatigue, and superiority in the global assessment by the patient and decrease in pain, for up to 16 weeks of follow-up, and high-quality evidence. With respect to safety outcomes, no differences were identified between baricitinib and adalimumab in the outcomes of death and serious infections, with a 52-week follow-up, and low-quality evidence. Baricitinib demonstrated a higher frequency of serious adverse events compared with adalimumab, with a 52-week follow-up, and moderate-quality evidence. Compared with tofacitinib, baricitinib demonstrated similarity in outcomes of ACR20 and serious adverse events, with follow-up between three and six months, and moderate-quality evidence. No RCTs or observational studies that compared baricitinib with other drugs offered by the Brazilian Public Health System (SUS) at the same treatment stage were identified. Budget impact analysis: The analysis presented by the applicant took into account the number of patients with RA being treated in SUS, with a linear growth projection for the following years. The proposed market share of baricitinib would be 2%, 6%, 10%, 12% and 15% in the five years after its incorporation, with patients changing from the drugs already incorporated homogeneously. Based on the cost data updated, the accumulated savings with the incorporation of baricitinib would be BRL 35,299,956 in five years. These values are potentially overestimated. The economic benefits of incorporating baricitinib may be less or absent.

Project Status: Completed

URL for project: http://conitec.gov.br/images/Consultas/Relatorios/EN2020/20200915_Report510_Baricitinib_ActiveRheumatoidArthritis.pdf

Year Published: 2020

URL for published report: http://conitec.gov.br/images/Relatorios/2020/Relatorio_Baricitinibe_Artrite_Reumatoide_510__2020_FINAL.pdf

URL for additional information: http://conitec.gov.br/recomendation-reports

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Brazil

Organisation Name: National Committee for Technology Incorporation (CONITEC)

Contact Address: Esplanada dos Ministérios, Bl. G, Ed. Sede, 8º andar, CEP: 70058-900

Contact Name: Clarice Moreira Portugal

Contact Email: clarice.portugal@saude.gov.br